Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
详细描述
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
干预措施: Bexxar (tositumomab) (Drug)
Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
干预措施: External beam radiotherapy (XRT) (Procedure)
Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
干预措施: Potassium Iodide (KI) (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: 12 weeks
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
次要结局
- Time-to-Progression (TTP)(2 years)
- Overall Response Rate (ORR)(12 weeks)
研究者
Susan Knox
Associate Professor of Radiation Oncology
Stanford University